Press Room

Press Release / Sep 20, 2019

Hovione announces successful end-of-phase 2 meeting with the FDA and outlines phase 3 program for minocycline topical gel

Hovione announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of moderate to severe inflammatory rosacea.

Cork, Ireland, 20th September 2019 – Hovione announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of moderate to severe inflammatory rosacea. At a recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Hovione received guidance for the design and clinical endpoints for HY01, topical minocycline gel 3%.

Based on the review of the Phase 2 clinical trial which enrolled 270 subjects across 3 treatment arms (HY01 Gel, 1%, HY01 Gel, 3%, and vehicle), FDA has supported advancement to Phase 3. The two, US based, pivotal studies will enroll 750 subjects each with the primary endpoints of absolute reduction in inflammatory lesions at week 12 compared to baseline and the achievement of “clear” or “almost clear” and a 2-grade reduction on the Investigator Global Assessment. Additionally, Hovione will complete a maximal use study in subjects with papulopustular rosacea. Assuming replication of the clinically significant improvements in subjects with moderate to severe papulopustular rosacea observed in Phase 2, Minocycline Topical Gel may offer a safer alternative to modified-release doxycycline, which is the only tetracycline approved for the treatment of inflammatory lesions of rosacea1. If approved, Minocycline Topical Gel will provide an important alternative treatment option targeted to the site of action and as thus avoiding the systemic side effects of oral doxycycline.

Hovione’s topical minocycline is the only program under development that uses a proprietary, crystalline form of the drug as minocycline base, conferring differentiated properties of potentially lower skin irritability based on its lower acidity and superior stability, as compared to its generic alternative. Hovione has secured patents for both the drug substance and the drug product globally with exclusivity through 2033. Hovione’s topical minocycline uses a novel proprietary excipient that reduces Trans-Epidermal Water Loss (TEWL) and provides a moisturizing, skin-barrier effect, potentially conferring relief to dry cracked skin of some rosacea patients. Minocycline is proven to have a potent anti-inflammatory effect,2 potentially superior to other tetracyclines. 

Guy Webster, M.D. Ph.D., dermatologist at the Sidney Kimmel School of Medicine of Thomas Jefferson University stated: “Approximately two-thirds of oral antibiotic prescriptions written by dermatologists are for doxycycline and minocycline for either acne or rosacea. Both compounds are only available for oral delivery and carry a risk of side effects. Hovione’s topical minocycline has a systemic exposure 1000 times lower than oral minocycline and provides a topical alternative with a moisturizing formulation. “

Hovione anticipates initiating the Phase 3 trial subject to entering into a strategic collaboration with a commercial partner, by fourth quarter of 2019, aiming at filing the NDA during 2021.

 

About Rosacea

Papulopustular Rosacea (PPR) is a chronic facial skin disease presenting most commonly in adulthood, with an estimated 16 million patients in the United States. PPR is characterized by inflammatory lesions (papules, pustules) on the nose, cheeks, chin and forehead.  PPR has been shown to have a negative impact on quality of life. Surveys conducted by the National Rosacea Society have shown that approximately 70% of rosacea patients experience lower self-confidence and lower self-esteem. Forty-one percent stated they avoid public contact and cancel social engagements during an exacerbation2

Strategic Partnership

Hovione is seeking strategic partners with proven regional or global commercial expertise in dermatology capable of maximizing the value of the First Topical Minocycline Gel for Rosacea.

 

About Hovione
Hovione is an international company with 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USMacauIreland, and Portugal, and development laboratories in Lisbon and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and cGMP-compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.

 

  1. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea.
    Del Rosso, James Q. et al.
    Journal of the American Academy of Dermatology, Volume 56, Issue 5, 791 – 802
     
  2. Minocycline: far beyond an antibiotic.
    Garrido-Mesa N. et al.
    British Journal of Pharmacology. 2013;169(2):337–352. doi:10.1111/bph.12139

 

 

Also in the Press Room

See All

The latest from CDMOs, CMOs, and suppliers featuring Thermo Fisher Scientific, Lonza, SK pharmteco/Lotte Biologics, Hovione, Sai Life Sciences, BioCina, Alcami, Piramal Pharma/IntoCell and Roquette. Formulation Development/Drug Product Manufacturing: Hovione Completes Initial $100-M Investment Cycle in US Operations Hovione, a CDMO of drug substances and drug products, has completed an initial $100-million investment cycle at its site in East Windsor, New Jersey, as part of a strategy to increase its US operations and enhance its integrated drug-substance, drug-product intermediate, and drug-product capabilities. Upon completion, the site will cover more than 200,000 square feet.   The initial expansion phase includes a 31,000-square-foot building that will house two size-3 spray dryers (PSD-3) designed for production of amorphous solid dispersions (ASDs). This investment more than doubles Hovione’s spray-drying capacity in the US by expanding capabilities for ASD development and commercial manufacturing. Construction is underway at the New Jersey site, with GMP operations planned to start in the second quarter of 2026.  As part of this expansion, Hovione has also acquired additional adjacent land to enable future growth at the East Windsor site. The 125,000-square-foot greenfield will support large-scale production, including continuous and batch tableting capacity, and introduce the latest pharmaceutical technologies and digital innovation with enhanced quality control and R&D capabilities.    Read the full article at DCATvci.org  

Press Clipping

Supplier News: Thermo Fisher, Lonza, SK pharmteco, Hovione & More

Oct 30, 2025

Today marks the start of CPhI Frankfurt, a huge trade show in Germany focused on the supply of pharmaceutical ingredients and other services to the drug industry. C&EN editor in chief Nick Perkins, life sciences editor Laura Howes, and reporter Aayushi Pratap are all there to meet drug outsourcing executives and take the pulse of the sector. In advance of CPhI, Cambrex and Wilmington PharmaTech both just announced big investments in US plants that make active pharmaceutical ingredients. And the Portuguese pharmaceutical services firm Hovione says it has completed a $100 million investment in New Jersey (story below). (...) Hovione invests in spray-drying in New Jersey The pharmaceutical services firm Hovione says it has spent $100 million to expand its operation in East Windsor, New Jersey. The facility spray-dries drug ingredients to create amorphous solid dispersions, which improve solubility and bioavailability. The Portuguese company says the new spray dryers will begin operating in the second quarter of 2026. The New Jersey facility opened in 2002, making Hovione one of the longest-established European pharmaceutical services firms in the US, CEO Jean-Luc Herbeaux says in a press release. Hovione says it has purchased land adjacent to the East Windsor site on which it can add new facilities for services such as spray-drying and drug tableting. Hovione is also investing at its sites in Ireland and Portugal. —Michael McCoy   Read the full article at CEN.acs.org  

Press Clipping

Oct. 28 Business Watch: More plants closing in Europe, Novartis to pay $12 billion for biotech firm

Oct 28, 2025

Developing drugs with poor water solubility remains a major challenge for pharmaceutical manufacturers, because solubility impacts bioavailability and effective drug delivery. The vast majority of small molecule drug candidates have low water solubility. For more than two decades, the most successful particle engineering technology to improve drug solubility and bioavailability has been spray drying with an amorphous solid dispersion (ASD) platform. Spray drying improves the solubility of oral drugs, inhalable particles, and excipients, and increases the stability of heat-sensitive drug products. Hovione, recognized globally for its industry-leading spray drying capabilities, has recently completed a $100 million investment cycle to enhance its operations in New Jersey. This initiative has successfully doubled Hovione’s spray-drying capacity in the US, strengthening its position in the industry. Hovione’s Expanded U.S. Site in East Windsor, NJ  The first phase of the expansion in East Windsor, NJ, delivers a new 31,000 square foot facility and houses two size-3 spray dryers (PSD-3). This additional capacity allows Hovione to meet increasing customer demand for ASD development and good manufacturing practice (GMP) commercial production. GMP operations are scheduled to commence in the second quarter of 2026.  Hovione has also acquired 15 acres of neighboring land, strategically positioning itself for future growth and evolving customer needs for U.S. manufacturing. The newly acquired greenfield site will provide future support for PSD-4–scale commercial production as well as continuous and batch tableting production. It will also be a hub for centralized logistics, enhanced quality control laboratories, and next-generation research and development facilities.  A Global CDMO with a Growing U.S. Footprint  Hovione has operated in New Jersey for more than two decades, establishing itself with a strong U.S. presence for the production of drug substances, intermediates, and finished drug products. A continued emphasis on an integrated service offering, including spray drying, supports delivering innovative medicines to patients more quickly.  The expansion of the East Windsor site addresses the rising demand for U.S. manufacturing and is an integral part of the company's ongoing global growth strategy, with facilities in Portugal, Ireland, and Macau. The company continues to bolster a cohesive network for drug development and commercial manufacturing unified by a corporate quality system and governance framework.  The integrated offering enhances development speed and eases technology transfers by unifying the team's technical skills, proprietary technologies, and digital platforms to efficiently produce drug substance to drug products at a single-site, through Hovione’s “one site, one partner” vision. Furthermore, Hovione’s strategic partnership model offers customers exclusive access to advanced technologies and resources while aiding in the optimization of their development programs and ensuring sustained value creation.  End-to-End Spray Drying and Particle Engineering: From Grams to Tons Hovione is a global leader in spray drying and particle engineering. Services include solubility enhancement and controlled-modified release via development and production of ASDs of both small and large molecules, supporting various modalities. ASD-HIPROS, Hovione’s proprietary spray drying screening platform, identifies optimal formulations that offer optimal performance and stability. By increasing production volume in the US, Hovione will meet customer demand for spray drying services:  Development services in the laboratory (1 g – 1 kg batches)  Pilot scale production (0.5 – 25 kg batches)  Small-scale production (5 – 200 kg batches)  Large-scale commercial manufacturing (50 – 400 kg batches) A Commitment to Sustainability  Hovione’s core values include a commitment to sustainability at all facilities. This commitment is reflected in a business strategy that focuses on improving the communities where the company operates. Hovione’s sustainability policy and strategy align with the UN Sustainable Development Goals and include adherence to science-based targets in line with the Paris Agreement to address climate change. Meeting these goals has required a dedication to process intensification and ensuring sustainability of manufacturing processes. This has been possible through strategic planning and commitments from senior management to ensure sustainability is addressed throughout the drug development life cycle.  Partner with a Technology-Leading CDMO for U.S. Manufacturing   As demand for poorly water-soluble drug formulations continues to rise in the U.S., expanding spray drying throughput is essential to meet the need for innovative therapeutics. With proven leadership in spray drying to manufacture ASDs, Hovione is able to support pharmaceutical companies by solving their solubility challenges efficiently and reliably.  Partnering with a CDMO that combines global leadership, advanced technologies, and the necessary manufacturing capacity in the U.S., drug developers can expedite time to market, ensure quality, and deliver innovative medicines to patients faster.  If your company is seeking access to the latest spray-drying capabilities, expanded U.S. manufacturing capacity, and an accelerated path to regulatory filing and commercialization, contact our team today.     

News

Hovione is Expanding Spray Drying Capacity for U.S. Drug Manufacturing

Oct 27, 2025